Expandable vein ligator catheter having multiple electrode leads, and method

ABSTRACT

A catheter includes a plurality of primary leads to deliver energy for ligating a hollow anatomical structure. Each of the primary leads includes an electrode located at the working end of the catheter. Separation is maintained between the primary leads such that each primary lead can individually receive power of selected polarity. The primary leads are constructed to expand outwardly to place the electrodes into apposition with an anatomical structure. High frequency energy can be applied from the leads to create a heating effect in the surrounding tissue of the anatomical structure. The diameter of the hollow anatomical structure is reduced by the heating effect, and the electrodes of the primary leads are moved closer to one another. Where the hollow anatomical structure is a vein, energy is applied until the diameter of the vein is reduced to the point where the vein is occluded. In one embodiment, a secondary lead is surrounded by the primary leads, and extends beyond the primary leads. The secondary lead includes an electrode at the working end of the catheter. The secondary lead can have a polarity opposite to the polarity of the primary leads in a bipolar configuration. The polarity of the leads can be switched and the catheter can be moved during treatment to ligate an extended length of the vein. The catheter can include a lumen to accommodate a guide wire or to allow fluid delivery.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 10/900,563(now U.S. Pat. No. 7,406,970), filed Jul. 28, 2004, which is acontinuation of application Ser. No. 09/866,517 (now U.S. Pat. No.6,769,433), filed May 25, 2001, which is a continuation of applicationSer. No. 09/267,756 (now U.S. Pat. No. 6,237,606), filed on Mar. 10,1999, which is a divisional of application Ser. No. 08/927,251 (now U.S.Pat. No. 6,200,312), filed on Sep. 11, 1997, the contents of which areall hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The invention relates generally to a method and apparatus for applyingenergy to shrink a hollow anatomical structure such as a vein, and moreparticularly, to a method and apparatus using an electrode device havingmultiple leads for applying said energy.

The human venous system of the lower limbs consists essentially of thesuperficial venous system and the deep venous system with perforatingveins connecting the two systems. The superficial system includes thelong or great saphenous vein and the short saphenous vein. The deepvenous system includes the anterior and posterior tibial veins whichunite to form the popliteal vein, which in turn becomes the femoral veinwhen joined by the short saphenous vein.

The venous system contains numerous one-way valves for directing bloodflow back to the heart. Venous valves are usually bicuspid valves, witheach cusp forming a sack or reservoir for blood which, under retrogradeblood pressure, forces the free surfaces of the cusps together toprevent retrograde flow of the blood and allows only antegrade bloodflow to the heart. When an incompetent valve is in the flow path, thevalve is unable to close because the cusps do not form a proper seal andretrograde flow of the blood cannot be stopped. When a venous valvefails, increased strain and pressure occur within the lower venoussections and overlying tissues, sometimes leading to additional valvularfailure. Two venous conditions which often result from valve failure arevaricose veins and more symptomatic chronic venous insufficiency.

The varicose vein condition includes dilation and tortuosity of thesuperficial veins of the lower limbs, resulting in unsightlydiscoloration, pain, swelling, and possibly ulceration. Varicose veinsoften involve incompetence of one or more venous valves, which allowreflux of blood within the superficial system. This can also worsen deepvenous reflux and perforator reflux. Current treatments of veininsufficiency include surgical procedures such as vein stripping,ligation, and occasionally, vein-segment transplant.

Ligation involves the cauterization or coagulation of vascular luminausing electrical energy applied through an electrode device. Anelectrode device is introduced into the vein lumen and positioned sothat it contacts the vein wall. Once properly positioned, RF energy isapplied to the electrode device thereby causing the vein wall to shrinkin cross-sectional diameter. A reduction in cross-sectional diameter, asfor example from 5 mm (0.2 in) to 1 mm (0.04 in), significantly reducesthe flow of blood through the vein and results in an effective ligation.Though not required for effective ligation, the vein wall may completelycollapse thereby resulting in a full-lumen obstruction that blocks theflow of blood through the vein.

One apparatus for performing venous ligation includes a tubular shafthaving an electrode device attached at the distal tip. Running throughthe shaft, from the distal end to the proximal end, are electricalleads. At the proximal end of the shaft, the leads terminate at anelectrical connector, while at the distal end of the shaft the leads areconnected to the electrode device. The electrical connector provides theinterface between the leads and a power source, typically an RFgenerator. The RF generator operates under the guidance of a controldevice, usually a microprocessor.

The ligation apparatus may be operated in either a monopolar or bipolarconfiguration. In the monopolar configuration, the electrode deviceconsists of an electrode that is either positively or negativelycharged. A return path for the current passing through the electrode isprovided externally from the body, as for example by placing the patientin physical contact with a large low-impedance pad. The current flowsfrom the ligation device to the low impedance pad. In a bipolarconfiguration, the electrode device consists of a pair of oppositelycharged electrodes separated by a dielectric material. Accordingly, inthe bipolar mode, the return path for current is provided by theelectrode device itself. The current flows from one electrode, throughthe tissue, and returns by way of the oppositely charged electrode.

To protect against tissue damage; i.e., charring, due to cauterizationcaused by overheating, a temperature sensing device is attached to theelectrode device. The temperature sensing device may be a thermocouplethat monitors the temperature of the venous tissue. The thermocoupleinterfaces with the RF generator and the controller through the shaftand provides electrical signals to the controller which monitors thetemperature and adjusts the energy applied to the tissue, through theelectrode device, accordingly.

The overall effectiveness of a ligation apparatus is largely dependenton the electrode device contained within the apparatus. Monopolar andbipolar electrode devices that comprise solid devices having a fixedshape and size limit the effectiveness of the ligating apparatus forseveral reasons. Firstly, a fixed-size electrode device typicallycontacts the vein wall at only one point on the circumference or innerdiameter of the vein wall. As a result, the application of RF energy ishighly concentrated within the contacting venous tissue, while the flowof RF current through the remainder of the venous tissue isdisproportionately weak. Accordingly, the regions of the vein wall nearthe point of contact collapse at a faster rate then other regions of thevein wall, resulting in non-uniform shrinkage of the vein lumen.Furthermore, the overall strength of the occlusion may be inadequate andthe lumen may eventually reopen. To avoid an inadequate occlusion RFenergy must be applied for an extended period of time. Application of RFenergy as such increases the temperature of the blood and usuallyresults in a significant amount of heat-induced coagulum forming on theelectrode and in the vein which is not desirable.

Secondly, the effectiveness of a ligating apparatus having a fixedelectrode device is limited to certain sized veins. An attempt to ligatea vein having a diameter that is substantially greater than theelectrode device can result in not only non-uniform shrinkage of thevein wall as just described, but also insufficient shrinkage of thevein. The greater the diameter of the vein relative to the diameter ofthe electrode device, the weaker the energy applied to the vein wall atpoints distant from the point of contact. Accordingly the vein wall islikely to not completely collapse prior to the venous tissue becomingover cauterized at the point of electrode contact. While coagulation assuch may initially occlude the vein, such occlusion may only betemporary in that the coagulated blood may eventually dissolve and thevein partially open. One solution for this inadequacy is an apparatushaving interchangeable electrode devices with various diameters. Such asolution, however, is both economically inefficient and tedious to use.

Hence those skilled in the art have recognized a need for an expandableelectrode device and a method capable of evenly distributing RF energyalong a circumferential band of a vein wall where the vein wall isgreater in diameter than the electrode device, and thereby provide morepredictable and effective occlusion of veins while minimizing theformation of heat-induced coagulum. The invention fulfills these needsand others.

SUMMARY OF THE INVENTION

Briefly, and in general terms, the present invention provides anapparatus and method for applying energy along a generallycircumferential band of a vein wall. The application of energy as suchresults in a more uniform and predictable shrinkage of the vein wall.

In one aspect of the invention, an apparatus for delivering energy toligate an anatomical structure comprises a catheter having a sheath, aworking end, and an opening formed at the working end of the catheter;an inner member disposed within the sheath such that the inner memberand the sheath are capable of being moved relative to one another; aplurality of leads, each lead having a distal end, the plurality ofleads being coupled with the inner member such that the distal ends ofthe plurality of leads extend out of the opening at the working end ofthe catheter when the position of the sheath changes in one directionrelative to the inner member, each lead being formed to move the distalend away from a longitudinal axis defined by the sheath when theplurality of leads are extended out the opening; wherein the distal endsof the leads are configured to deliver energy to the anatomicalstructure.

In another aspect of the invention, the apparatus includes a secondarylead having a secondary distal end. The secondary lead is coupled withthe inner member such that the distal end of the secondary lead isextended out of the opening at the working end of the catheter when theposition of the inner member changes in one direction relative to thesheath.

In another aspect of the invention, the distal ends of the leads areelectrically connected to a power source such that the polarity of eachlead can be switched. Where there is a secondary lead electrode, theplurality of leads can be connected to the power source such that thepolarity of the leads can be changed independently of the polarity ofthe secondary lead.

In another aspect, the leads include primary leads which generallysurround the secondary lead at the working end of the catheter. Thedistal ends of the primary leads are located between the distal end ofthe secondary lead and the inner member.

In yet another aspect, the invention comprises a method of applyingenergy to a hollow anatomical structure from within the structure. Themethod includes the step of introducing a catheter into the anatomicalstructure; the catheter having a working end and a plurality of leads,each lead having a distal end, and each lead being connected to a powersource. The method also includes the step of expanding the leadsoutwardly through the distal orifice and expanding the leads until eachelectrode contacts the anatomical structure. The method further includesthe step of applying energy to the anatomical structure from the distalend of the leads, until the anatomical structure collapses.

In another aspect of the invention, the method also includes the step ofintroducing a catheter into the anatomical structure where the catheterhas a secondary lead that has a distal portion that is greater in lengththan the primary-lead distal portions and is generally surrounded by theprimary leads. The secondary lead also has an electrode at the distalend. The method also includes the steps of extending the primary andsecondary leads through the orifice until each primary-lead electrodecontacts the anatomical structure, and controlling the power source sothat adjacent primary leads are of opposite polarity while maintainingthe secondary lead so that it is electrically neutral. Upon collapse ofthe anatomical structure around the primary leads, the polarity of theprimary leads is switched so that they are all of the same polarity.Upon switching the polarity of the primary leads so that they are of thesame polarity, controlling the power source so that the secondary leadis of opposite polarity relative to the primary leads. The method, in afurther aspect, comprises the step of moving the catheter in theanatomical structure while continuing to apply energy to the anatomicalstructure to lengthen the area of ligation.

In another aspect of the invention, external compression is used toinitially force the wall of the vein to collapse toward the catheter.The application of energy molds the vein to durably assume the collapsedstate initially achieved mechanically by the external compression. Atourniquet can be used to externally compress or flatten the anatomicalstructure and initially reduce the diameter of the hollow anatomicalstructure. The pressure applied by the tourniquet can exsanguinate bloodfrom the venous treatment site, and pre-shape the vein in preparation tobe molded to a ligated state. An ultrasound window formed in thetourniquet can be used to facilitate ultrasound imaging of theanatomical structure being treated through the window.

These and other aspects and advantages of the present invention willbecome apparent from the following more detailed description, when takenin conjunction with the accompanying drawings which illustrate, by wayof example, embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram of an energy application system with a partialcutaway view of a catheter showing both the working end and theconnecting end and incorporating a preferred embodiment of the presentinvention;

FIG. 2 is a cross-sectional view of the working end of a firstembodiment of a catheter in accordance with the invention depicting theelectrodes in a fully extended position;

FIG. 2 a is an end view of the working end of the first embodiment ofthe catheter taken along line 2 a-2 a of FIG. 2;

FIG. 3 is a cross-sectional view of the working end of the firstembodiment depicting the electrodes in a fully retracted position;

FIG. 4 is a cross-sectional view of the working end of a second catheterin accordance with principles of the invention depicting the electrodesin a fully extended position;

FIG. 4 a is an end view of the second embodiment of the invention takenalong line 4 a-4 a of FIG. 4;

FIG. 5 is a cross-sectional view of the working end of the secondembodiment of the catheter of FIG. 4 depicting the electrodes in a fullyretracted position;

FIG. 6 is a cross-sectional view of an anatomical structure containingthe catheter of FIG. 2 with the electrodes in apposition with theanatomical structure;

FIG. 6 a is an end view of the anatomical structure containing thecatheter taken along line 6 a-6 a of FIG. 6;

FIGS. 7 a through 7 c are cross-sectional views of the anatomicalstructure containing a catheter in accordance with the first embodimentof the invention and depicting the anatomical structure at variousstages of ligation;

FIG. 8 is a cross-sectional view of an anatomical structure containing acatheter in accordance with the second embodiment of the invention asdepicted in FIG. 4;

FIG. 8 a is an end view of the anatomical structure containing thecatheter taken along line 8 a-8 a of FIG. 8; and

FIGS. 9 a and 9 b are cross-sectional views of the anatomical structurecontaining the catheter in accordance with the second embodiment of theinvention and depicting the anatomical structure at various stages ofligation;

FIG. 10 is a cross-sectional view of the working end of a thirdembodiment of a catheter in accordance with the invention depicting theelectrodes in a fully extended position;

FIG. 10 a is an end view of the working end of the third embodiment ofthe catheter taken along line 10 a-10 a of FIG. 10;

FIG. 11 is a cross-sectional view of the working end of the thirdembodiment depicting the electrodes in a fully retracted position;

FIG. 11 a is a view taken along line 11 a-11 a of FIG. 11

FIG. 12 is a cross-sectional view of an anatomical structure containingthe catheter of FIG. 10 with the electrodes in apposition with theanatomical structure;

FIG. 13 is a cross-sectional view of the anatomical structure containingthe catheter of FIG. 10 where the anatomical structure is being ligatedby the application of energy from the electrodes.

FIG. 14 is a cross-sectional view of an anatomical structure containingthe catheter of FIG. 10 with the electrodes in apposition with theanatomical structure where external compression is being applied toreduce the diameter of the hollow structure before the application ofenergy from the electrodes to ligate the structure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Turning now to the drawings with more particularity wherein likereference numerals indicate like or corresponding elements among thefigures, shown in FIG. 1 is a catheter 10 for applying energy to ananatomical structure such as a vein. The catheter 10 includes an outersheath 12 having a distal orifice 14 at its working end 15. Theconnector end 17 of the outer sheath 12 is attached to a handle 16 thatincludes an electrical connector 18 for interfacing with a power source22, typically an RF generator, and a microprocessor controller 23. Thepower source 22 and microprocessor 23 are usually contained in one unit.The controller 23 controls the power source 22 in response to externalcommands and data from a sensor, such as a thermocouple, located at anintraluminal venous treatment site. In another embodiment, the user canselect a constant power output so that automated temperature control isnot present and the user can manually adjust the power output in view ofthe temperature on a display readout. The catheter 10 includes anexpandable electrode device 24 (partially shown) that moves in and outof the outer sheath 12 by way of the distal orifice 14. The electrodedevice includes a plurality of electrodes which can be expanded bymoving the electrodes within the shaft, or by moving the outer shaftrelative to the electrodes. Although FIG. 1 illustrates a plurality ofelectrodes surrounding a single central electrode, different electrodeconfigurations will be described for the catheter.

Contained within the outer sheath 12 is an inner sheath 28 or innermember. A fluid port 21 communicates with the interior of the outersheath 12. The catheter 10 can be periodically flushed out with salinethrough the port 21. The flushing fluid can travel between the outersheath and the inner sheath. The port also allows for the delivery ofdrug therapies. Flushing out the catheter prevents the buildup ofbiological fluid, such as blood, within the catheter 10. The treatmentarea of the hollow anatomical structure such as a vein can be flushedwith a fluid such as saline, or a dielectric fluid, in order to evacuateblood from the treatment area of the vein so as to prevent the formationof coagulum or thrombosis. The use of a dielectric fluid can minimizeunintended heating effects away from the treatment area. The dielectricfluid prevents the current of RF energy from flowing away from the veinwall.

In one embodiment, the catheter 10 includes a lumen which begins at thedistal tip of the outer sheath 12 and runs substantially along the axisof the outer sheath 12 before terminating at the guide-wire port 20 ofthe handle 16. A guide wire can be introduced through the lumen of thecatheter 10 for use in guiding the catheter to the desired treatmentsite. Where the catheter is sized to treat smaller veins, the outerdiameter of the catheter may not allow for a fluid flush between theouter sheath 12 and the inner sheath 28. However, a fluid flush can beintroduced through the lumen for the guide wire in such an embodiment.

Referring now to FIGS. 2, 2 a, 3, 4, 4 a and 5, the outer sheath 12includes a shell 44 and a tip portion 46. To provide an atraumatic tipfor the catheter 10 as it is manipulated through the vein, the tip 46 ispreferably tapered inward at its distal end or is “nosecone” shaped. Thetip 46, however, can have other shapes that facilitate tracking of thecatheter 10 over a guide wire and through the bends in the venousvascular system. The nosecone-shaped tip 46 can, for example, befabricated from a polymer having a soft durometer, such as 70 Shore A.The shell 44 comprises a biocompatible material having a low coefficientof friction. In one configuration, the outer sheath 12 is sized to fitwithin a venous lumen and for example may be between 5 and 9 French,which corresponds to a diameter of between 1.7 mm (0.07 in) and 3.0 mm(1.2 in), or other sizes as appropriate.

The electrode device 24 contains a number of leads, including insulatedprimary leads 30 and, in some embodiments, a secondary lead 31.Preferably, the leads are connected to the power source 22 (FIG. 1) suchthat the polarity of the leads may be switched as desired. Alternately,a microprocessor controller can be used to switch the polarity, as wellas control other characteristics of the power for the electrode device.Thus the electrode device can operate in either a bipolar or a monopolarconfiguration. When adjacent primary leads 30 have opposite polarity theelectrode device 24 operates as a bipolar electrode device. When theprimary leads 30 are commonly charged the electrode device 24 canoperate as a monopolar electrode device. When the primary leads 30 arecommonly charged, and a secondary lead 31 has an opposite polarity, theelectrode device 24 operates as a bipolar electrode device. Theembodiment of the invention shown in FIGS. 2 and 3 depict an electrodedevice 24 having four primary leads 30 and a secondary lead 31, whilethe embodiment of the invention shown in FIGS. 4 and 5 depict anelectrode device 24 having only four primary leads. The invention is notlimited to four primary leads 30; more or fewer leads may be used ineither embodiment. The number of leads can be dependent on the size ordiameter of the hollow anatomical structure to be treated. The apposedelectrodes should be kept within a certain distance of one another.Larger vessels may require more primary leads to ensure proper currentdensity and proper heat distribution.

The insulation on each of the leads 30, 31 may be removed at the distalend 32, 33 to expose the conductive wire. In the first configuration asshown in FIGS. 2, 2 a, and 3, the electrode 34 has a hemisphericalshape. In a second configuration, the electrode can have either agenerally spherical shape or a spoon shape. As shown in FIGS. 4, 4 a and5, the electrodes have a spoon shape which can be combined to form asphere or other shape so as to minimize its profile when the veincollapses. The electrodes 34 are either integrally formed at the distalend 32, soldered, or otherwise formed to the distal end of each primarylead 30. It is to be understood that when the distal end 32 is referredto as acting as an electrode, this is not limited to where the electrode34 is integrally formed at the distal end 32. For example, the distalend can apply energy to the surrounding tissue where there is anelectrode integrally formed at the distal end, or where an electrode isseparately soldered to the distal end, or where there is another energydelivery device located at the distal end. The electrode 34 typicallyhas a diameter greater than the diameter of the primary lead 30. Forexample, the primary lead 30 may have a diameter ranging from 0.18 mm(0.007 in.) to 0.28 mm (0.011 in.), while the electrode 34 has adiameter of 0.36 mm (0.014 in.) to 0.51 mm (0.020 in.). The primaryleads 30 and the electrodes 34 are preferably made from abiologically-compatible material such as stainless steel. The insulationsurrounding the primary leads 30 generally has a thickness of between0.03 mm (0.001 in.) and 0.06 mm (0.0025 in.), resulting in a combinedlead-insulation diameter of between 0.23 mm (0.009 in.) and 0.41 mm(0.016 in.). In an alternate configuration, as shown in FIGS. 2 and 3,each primary lead 30 is strip-shaped with a width from 0.76 mm (0.03in.) to 1.0 mm (0.04 in) and a thickness of approximately 0.13 mm (0.005in.), while the secondary lead 31 is typically tubular-shaped. It shouldbe noted that these dimensions are provided for illustrative purposes,and not by way of limitation. A hemispherically shaped electrode 34 isformed at the distal end, as for example, by sanding down asixteenth-inch (1.6 mm) diameter sphere which is soldered to the distalend 32 of the primary lead 30. The electrodes can also be constructed bystamping the desired shape or configuration from the conductive lead.The electrode is integral with the lead, and the remainder of the leadis insulated. The distal end 33 of the secondary lead 31 preferablyincludes a generally spherically-shaped electrode 35.

An alignment device 36 arranges the leads 30, 31 such that they aremounted to the catheter at only their proximal ends and so thatseparation is maintained between the leads within, and distal to thealignment device. The leads can form cantilevers when mounted on thealignment device. A preferred configuration of the alignment device 36includes a plurality of off-center, axially-aligned lumina 38 which aresubstantially symmetrically positioned relative to the axis of thealignment device 36. The alignment device 36 is formed, for example, byextruding the plurality of axially-aligned lumina 38 through a solidcylinder composed of a dielectric material, such as polyamide. Each lead30 passes through an individual off-center lumen 38 and exits out therear of the alignment device 36. The alignment device 36 may furtherinclude a central lumen 48 that may be aligned with the axis. In someembodiments the central lumen 48 is used for accepting a guide wire orfor the delivery or perfusion of medicant and cooling solution to thetreatment area during application of RF energy. In other embodiments,the central lumen 48 may be used for the secondary lead 31. Thealignment device 36 may also further include an auxiliary lumen 47 foradditional leads, such as the leads of a thermocouple used as atemperature sensor. The alignment device 36 comprises a dielectricmaterial to prevent or minimize any coupling effect the leads 30, 31 mayhave with each other and, if present, the guide wire. The length of thealignment device is, for example, 12.5 mm (0.5 in.) to 19.0 mm (0.75in.) in one embodiment. However, these dimensions are provided forpurposes of illustration and not by way of limitation.

In the embodiment of the invention shown in FIGS. 2, 2 a and 3, theinner sheath 28 is attached to the alignment device 36 and extendsbeyond the rear 37 of the alignment device. Preferably, the inner sheath28 completely surrounds the exterior wall of the alignment device 36 andis mounted to it by adhesive or press fit or in other manner such thatit remains in a fixed position relative to the inner sheath. The innersheath and alignment device can act as an inner member relative to theouter sheath. The inner sheath 28 comprises a biocompatible materialwith a low coefficient of friction. The inner sheath 28 provides apathway for the interconnection between the leads 30, 31 and theelectrical connector 18 (FIG. 1). This interconnection may occur in anyof several ways. The leads 30, 31 themselves may be continuous and runthe entire length of the inner sheath 28. In the alternative (notshown), the positively charged leads 30, 31 may couple with a commonpositively charged conductor housed in the inner sheath 28. Likewise,the negatively charged leads 30, 31 may couple with a common negativeconductor. Preferably, the leads 30, 31 are connected to a conductorthat allows for the polarity of the leads to be switched. The conductormay comprise, for example, a 36 gauge copper lead with a polyurethanecoating. The coupling may occur at any point within the inner sheath 28.To reduce the amount of wire contained in the catheter, it isadvantageous to couple the leads 30, 31 at the point where the leadsexit the rear 37 of the alignment device 36. To add further stability tothe electrode device 24, it is preferred that bonding material 40surround the leads 30, 31 at the front end of the alignment device 36.In this embodiment, the leads 30, 31 exit through the distal orifice 14as the outer sheath 12 is retracted backwards over the alignment device36. The inwardly tapered tip 46 impedes the retracting movement of theouter sheath 12 to prevent the exposure of the alignment device 36.

FIG. 3 shows the leads 30 and 31 in the retracted position where allleads are within the nosecone-shaped tip portion 46 and the outer shell44. The alignment device 36 has been moved relative to the outer shell44. The soft nosecone provides an atraumatic tip for when the catheteris maneuvered through the tortuous venous system. The electrode at thedistal end of the secondary lead 31 can be sized to approximately thesame size as the opening formed in the nosecone 46. The nosecone forms aclosed atraumatic tip together with the electrode of the secondary leadwhen the alignment device is retracted into the outer sheath of thecatheter. This can present an atraumatic tip even where the nosecone isnot constructed from a material having a soft durometer.

Referring now to FIGS. 4 and 5, in another embodiment, the alignmentdevice 36 is attached to the outer sheath 12 and thereby remainsimmobile in relation to it. The inner sheath 28 is movably positioned atthe rear of the alignment device 36 and again provides a pathway for theinterconnection between the primary leads 30 and the electricalconnector 18 (FIG. 1). In some embodiments the inner sheath 28 containsa guide-wire tube 49 that runs the entire length of the inner sheath.The guide-wire tube 49 is aligned to communicate with the central lumen48 of the alignment device 36 at one end and with the guide-wire port 20(FIG. 1) at the other end. The primary leads 30 may be continuous andrun the entire length of the inner sheath 28 or they may be coupled tocommon leads as previously described. The primary leads 30 are securedto the front end 27 of the inner sheath 28, as for example with apotting material 50, so that the movement of the inner sheath 28 resultsin a corresponding movement of the primary leads 30 through the lumina38 of the alignment device 36. In this embodiment, the primary leads 30are not secured to the alignment device 36 and in essence arefree-floating leads-in the axial direction. The primary leads 30 travelthrough the alignment device 36 and exit through the distal orifice 14as the front end of the inner sheath 28 is moved toward the rear 37 ofthe alignment device 36.

In the above embodiments, the primary leads 30 are formed, e.g., arcedor bent, to move away from each other and thereby avoid contact. The“distal portion” of the primary leads 30 is the portion of the leadwhich extends from the front end of the alignment device 36 when theleads are fully extended through the distal orifice 14. It is preferredthat the distal portions 42 are formed to move radially outward fromeach other relative to the axis of the alignment device 36 and form asymmetrical arrangement. This is shown in both the embodiments of FIG. 2a and FIG. 4 a. The degree of arc or bend in the primary leads 30 may beany that is sufficient to radially expand the leads as they exit theouter sheath 12 through the distal orifice 14. It is essential that thedegree of the arc or bend be sufficient to provide enough force so thatthe primary leads 30 expand through blood and the electrodes 34 come inapposition with the vein wall. The electrodes are preferably partiallyembedded in the vein wall to assure full contact. The rounded portion ofthe electrode is embedded into the vein wall to achieve full surfaceapposition so that the entire uninsulated surface area of the electrodeis in contact with venous tissue for effective current distribution. Thesurface area of the electrodes in contact with the venous tissuepreferably is sufficient to avoid a high current density which may leadto spot heating of the venous tissue. The heating effect is preferablydistributed along a circumferential band of the vein. The apposedelectrodes should be spaced no more than 4 or 5 millimeters from oneanother along the circumference of the vein. Thus, the electrodearrangement is related to the size or diameter of the vein beingtreated. Other properties of the primary leads 30, such as lead shapeand insulation thickness, affect the push force of the lead and thedegree of arc or bend must be adjusted to compensate for these factors.For example, in one configuration of the electrode device 24, a wirehaving a diameter of between 0.18 mm (0.007 in) and 0.28 mm (0.011 in)with a total insulation thickness of between 0.05 mm (0.002 in) to 0.13mm (0.005 in) is arced or bent at an acute angle to provide sufficientapposition with the anatomical structure. It is to be understood thatthese dimensions are provided for illustrative purposes, and not by wayof limitation.

Other techniques for expanding the leads outwardly once they have beenextended from the working end of the catheter may be possible. Forexample, the leads may be straight but are mounted in the alignmentdevice at an angle such that they are normally directed outward.

For increased appositional force, it is preferred that the primary leads30 be strip-shaped, that is rectangular in cross section, withdimensions, for example, of a width from 0.76 mm (0.030 in.) to 1.0 mm(0.039 in) and a thickness of approximately 0.13 mm (0.005 in.). Therectangular cross section provides increased resistance to bending inthe width dimension but allows bending more freely in the thicknessdimension. This strip-shaped configuration of the primary leads 30 isshown in FIGS. 2, 2 a, and 3 and provides for increased stability in thelateral direction while allowing the necessary bending in the radialdirection. In FIGS. 2, 2 a, and 3, each primary lead comprises arectangular cross section mounted in relation to the catheter such thatthe thinner dimension of the rectangular cross section is aligned withthe direction of expansion of the lead. The leads are less likely tobend sideways when expanded outward, and a uniform spacing between leadsis more assured. Uniform spacing promotes uniform heating around thevenous tissue which is in apposition with the electrodes at the distalends of the leads.

The length of the distal portion of the leads 30 also affects theconfiguration of the electrode device 24. The maximum distance betweentwo mutually opposed electrodes 34; i.e., the effective diameter of theelectrode device 24, is affected by the bend degree and length of thedistal portion 42. The longer the length of the distal portion 42 thegreater the diameter of the electrode device 24. Accordingly, bychanging the distal portion 42 length and arc or bend degree, thecatheter 10 can be configured for use in differently sized anatomicalstructures.

Different numbers of leads 30, 31 can be employed with the catheter. Thenumber of leads 30, 31 is limited by the diameter of the alignmentdevice 36 and the number of lumina 36, 38, 47 that can be extrudedthrough the alignment device. In a bipolar configuration, an even numberof primary leads 30 are preferably available to form a number ofoppositely charged electrode pairs. The electrodes in apposition withthe anatomical structure should be maintained within a certain distanceof each other. In a monopolar configuration, any number of commonlycharged leads 30 can be present. In the monopolar mode, distribution ofRF energy through the anatomical tissue is obtained by creating a returnpath for current through the tissue by providing a return device at apoint external from the tissue, such as a large metal pad.

Now referring again to FIG. 1, an actuator 25 controls the extension ofthe electrode device 24 through the distal orifice 14. The actuator 25may take the form of a switch, lever, threaded control knob, or othersuitable mechanism, and is preferably one that can provide fine controlover the movement of the outer sheath 12 or the inner sheath 28, as thecase may be. In one embodiment of the invention, the actuator 25(FIG. 1) interfaces with the outer sheath 12 (FIGS. 2, 2 a and 3) tomove it back and forth relative to the inner sheath 28. In anotherembodiment the actuator 25 (FIG. 1) interfaces with the inner sheath 28(FIGS. 4, 4 a and 5) to move it back and forth relative to the outersheath 12. The relative position between the outer sheath and innersheath is thus controlled, but other control approaches may be used.

Referring again to FIGS. 2, 2 a, 3, 4, 4 a and 5, the catheter 10includes a temperature sensor 26, such as a thermocouple. Thetemperature sensor 26 is mounted in place on an electrode 34 so that thesensor 26 is nearly or is substantially flush with the exposed surfaceof the electrode 34. The sensor 26 is shown in the drawings asprotruding from the electrodes for clarity of illustration only. Thesensor 26 senses the temperature of the portion of the anatomical tissuethat is in apposition with the exposed electrode surface. Monitoring thetemperature of the anatomical tissue provides a good indication of whenshrinkage of the tissue is ready to begin. A temperature sensor 26placed on the electrode facing the anatomical tissue provides anindication of when shrinkage occurs (70 degrees C. or higher) and whensignificant amounts of heat-induced coagulum may begin to form on theelectrodes (at 85 degrees C. or higher). Therefore maintaining thetemperature above 70 degrees Centigrade produces a therapeutic shrinkageof the anatomical structure. Application of the RF energy from theelectrodes 34 is halted or reduced when the monitored temperaturereaches or exceeds the specific temperature that was selected by theoperator, typically the temperature at which anatomical tissue begins tocauterize. The temperature sensor 26 interfaces with the controller 23(FIG. 1) through a pair of sensor leads 45 which preferably run throughthe auxiliary lumen 47 and then through the inner sheath 28. The signalsfrom the temperature sensor 26 are provided to the controller 23 whichcontrols the magnitude of RF energy supplied to the electrodes 34 inaccordance with the selected temperature criteria and the monitoredtemperature. Other techniques such as impedance monitoring, andultrasonic pulse echoing can be utilized in an automated system whichshuts down or regulates the application of RF energy from the electrodesto the venous section when sufficient shrinkage of the vein is detectedand to avoid overheating the vein.

Referring now to FIGS. 6, 6 a and 7 a through 7 c, in the operation ofone embodiment of the catheter 10, the catheter is inserted into ahollow anatomical structure, such as a vein 52. The catheter is similarto the embodiment discussed in connection with FIGS. 2 and 3. Thecatheter 10 further includes an external sheath 60 through which a fluidcan be delivered to the treatment site. In this embodiment, the fluidport (not shown) communicates with the interior of the external sheath60, and fluid is delivered from between the external sheath 60 and theouter sheath 12. The external sheath 60 surrounds the outer sheath 12 toform a coaxial channel through which fluid may be flushed.

Fluoroscopy, ultrasound, an angioscope imaging technique, or othertechnique may be used to direct the specific placement of the catheterand confirm the position in the vein. The actuator (not shown) is thenoperated to shift the outer sheath relative to the inner sheath byeither retracting the outer sheath 12 backward or advancing the innersheath 28 forward to expose the leads 30, 31 through the distal orifice14. As the leads 30, 31 exit the distal orifice 14, the primary leads 30expand radially outward relative to the axis of the alignment device 36,while the secondary lead 31 remains substantially linear. The primaryleads 30 continue to move outward until apposition with the vein wall 54occurs and the outward movement of the primary leads 30 is impeded. Theprimary leads 30 contact the vein along a generally circumferential bandof the vein wall 54. This outward movement of the primary leads 30occurs in a substantially symmetrical fashion. As a result, theprimary-lead electrodes 34 are substantially evenly spaced along thecircumferential band of the vein wall 54. The central-lead electrode 35is suspended within the vein 52 without contacting the vein wall 54.

When the electrodes 34 are positioned at the treatment site of the vein,the power supply 22 is activated to provide suitable RF energy,preferably at a selected frequency from a range of 250 kHz to 350 MHZ.One suitable frequency is 510 kHz. One criterion used in selecting thefrequency of the energy to be applied is the control desired over thespread, including the depth, of the thermal effect in the venous tissue.Another criterion is compatibility with filter circuits for eliminatingRF noise from thermocouple signals.

In bipolar operation, the primary leads 30 are initially charged suchthat adjacent leads are oppositely charged while the secondary lead iselectrically neutral. These multiple pairs of oppositely charged leads30 form active electrode pairs to produce an RF field between them.Thus, discrete RF fields are set up along the circumferential band ofthe vein wall 54. These discrete fields form a symmetrical RF fieldpattern along the entire circumferential band of the vein wall 54, asadjacent electrodes 34 of opposite polarity produce RF fields betweeneach other. A uniform temperature distribution can be achieved along thevein wall being treated.

The RF energy is converted within the adjacent venous tissue into heat,and this thermal effect causes the venous tissue to shrink, reducing thediameter of the vein. A uniform temperature distribution along the veinwall being treated avoids the formation of hot spots in the treatmentarea while promoting controlled uniform reduction in vein diameter. Thethermal effect produces structural transfiguration of the collagenfibrils in the vein. The collagen fibrils shorten and thicken incross-section in response to the heat from the thermal effect. As shownin FIG. 7 a, the energy causes the vein wall 54 to collapse around theprimary-lead electrodes 34. The wall 54 continues to collapse untilfurther collapse is impeded by the electrodes 34. The electrodes arepressed farther and farther together by the shrinking vein wall 54 untilthey touch and at that point, further collapse or ligation of the wall54 is impeded. Upon collapse of the vein wall 54 around the primary-leadelectrodes 34, the polarity of the primary-lead electrodes is switchedso that all primary-lead electrodes are commonly charged. The switchingof polarity for the leads need not be instantaneous. The application ofRF energy can be ceased, the polarity switched, and then RF energy isapplied again at the switched polarity. The secondary-lead electrode 35is then charged so that its polarity is opposite that of theprimary-lead electrodes 34. The RF field is set up between theprimary-lead electrodes 34 and the secondary-lead electrode 35.

The catheter 10 is then pulled back while energy is applied to theelectrode device. As shown in FIG. 7 b, while the catheter 10 is beingpulled back, the primary-lead electrodes 34 remain in apposition withthe vein wall 54 while the secondary-lead electrode 35 comes in contactwith the portion of the vein wall previously collapsed by theprimary-lead electrodes 34. Accordingly, RF energy passes through thevein wall 54 between the primary-lead electrodes 34 and thesecondary-lead electrode 35 and the vein wall continues to collapsearound the secondary-lead electrode 35 as the catheter 10 is beingretracted. As shown in FIG. 7 c, ligation in accordance with this methodresults in an occlusion along a length of the vein 52. A lengthyocclusion, as opposed to an acute occlusion, is stronger and lesssusceptible to recanalization.

A similar result is achieved when the catheter 10 having both primaryand secondary leads is operated in a monopolar manner. In a monopolaroperation, the secondary-lead electrode 35 remains neutral, while theprimary leads 30 are commonly charged and act in conjunction with anindependent electrical device, such as a large low-impedance return pad(not shown) placed in external contact with the body, to form a seriesof discrete RF fields. These RF fields are substantially evenly spacedaround the circumference of the vein and travel along the axial lengthof the vein wall causing the vein wall to collapse around theprimary-lead electrodes. Upon collapse of the vein wall, thesecondary-lead electrode is charged to have the same polarity as that ofthe primary-lead electrodes. The electrode device is retracted and thevein wall collapses as described in the bipolar operation.

In either bipolar or monopolar operation the application of RF energy issubstantially symmetrically distributed through the vein wall,regardless of the diameter of the vein 52. This symmetrical distributionof RF energy increases the predictability and uniformity of theshrinkage and the strength of the occlusion. Furthermore, the uniformdistribution of energy allows for the application of RF energy for ashort duration and thereby reduces or avoids the formation ofheat-induced coagulum on the electrodes 34. The leads, including thenon-convex outer portion of the electrode, are insulated to furtherprevent heating of the surrounding blood.

Fluid can be delivered before and during RF heating of the vein beingtreated through a coaxial channel formed between the external sheath 60and the outer sheath 12. It is to be understood that another lumen canbe formed in the catheter to deliver fluid to the treatment site. Thedelivered fluid displaces or exsanguinates blood from the vein so as toavoid heating and coagulation of blood. Fluid can continue to bedelivered during RF treatment to prevent blood from circulating back tothe treatment site. The delivery of a dielectric fluid increases thesurrounding impedance so that RF energy is directed into the tissue ofthe vein wall.

Referring now to FIGS. 8, 8 a, 9 a and 9 b, in the operation of analternate embodiment of the catheter 10 that may be used with a guidewire 53. As in the previous embodiment, the catheter 10 is inserted intoa hollow anatomical structure, such as a vein 52. The guide wire 53 isadvanced past the point where energy application is desired. Thecatheter 10 is then inserted over the guide wire 53 by way of thecentral lumen 48 and the guide wire tube 49 (FIG. 4) and is advancedover the guide wire through the vein to the desired point. The guidewire 53 is typically pulled back or removed before RF energy is appliedto the electrode device 24.

The actuator 25 (FIG. 1) is then manipulated to either retract the outersheath 12 backward, or advance the inner sheath 28 forward to expose theleads 30 through the distal orifice 14. The leads 30 exit the distalorifice 14 and expand radially outward relative to the axis of thealignment device 36. The leads 30 continue to move outward untilapposition with the vein wall 54 occurs. The leads 30 contact the veinalong a generally circumferential band of the vein wall 54. This outwardmovement of the leads occurs in a substantially symmetrical fashion. Asa result, the electrodes 34 are substantially evenly spaced along thecircumferential band of the vein wall 54. Alternately, the electrodescan be spaced apart in a staggered fashion such that the electrodes donot lie along the same plane. For example, adjacent electrodes canextend different lengths from the catheter so that a smallercross-sectional profile is achieved when the electrodes are collapsedtoward one another.

When the electrodes 34 are positioned at the treatment site of the vein,the power supply 22 is activated to provide suitable RF energy to theelectrodes 34 so that the catheter 10 operates in either a bipolar ormonopolar manner as previously described. As shown in FIGS. 9 a and 9 b,the energy causes the vein wall 54 to collapse around the electrodes 34causing the leads to substantially straighten and the electrodes tocluster around each other. The wall 54 continues to collapse untilfurther collapse is impeded by the electrodes 34 (FIG. 9 b). At thispoint the application of energy may cease. The electrodes can beconfigured to form a shape with a reduced profile when collapsedtogether. The electrodes can also be configured and insulated tocontinue applying RF energy after forming a reduced profile shape by thecollapse of the vein wall. The catheter 10 can be pulled back to ligatethe adjacent venous segment. If a temperature sensor 26 is included, theapplication of energy may cease prior to complete collapse if thetemperature of the venous tissue rises above an acceptable level asdefined by the controller 23.

Where the catheter includes a fluid delivery lumen (not shown), fluidcan be delivered before and during RF heating of the vein being treated.The fluid can displace blood from the treatment area in the vein toavoid the coagulation of blood. The fluid can be a dielectric medium.The fluid can include an anticoagulant such as heparin which canchemically discourage the coagulation of blood at the treatment site.

After completing the procedure for a selected venous section, theactuator mechanism causes the primary leads to return to the interior ofthe outer sheath 12. Either the outer sheath or the inner sheath ismoved to change the position of the two elements relative to oneanother. Once the leads 30 are within the outer sheath 12, the catheter10 may be moved to another venous section where the ligation process isrepeated. Upon treatment of all venous sites, the catheter 10 is removedfrom the vasculature. The access point of the vein is then suturedclosed or local pressure is applied until bleeding is controlled.

Another embodiment of the catheter is illustrated in FIG. 10. The innermember or sheath 28 is contained within the outer sheath 12. The innersheath is preferably constructed from a flexible polymer such aspolyimide, polyethylene, or nylon, and can travel the entire length ofthe catheter. The majority of the catheter should be flexible so as tonavigate the tortuous paths of the venous system. A hypotube having aflared distal end 33 and a circular cross-sectional shape is attachedover the distal end of the inner sheath 28. The hypotube is preferablyno more than about two to three centimeters in length. The hypotube actsas part of the conductive secondary lead 31. An uninsulated conductiveelectrode sphere 35 is slipped over the hypotube. The flared distal endof the hypotube prevents the electrode sphere from moving beyond thedistal end of the hypotube. The sphere is permanently affixed to thehypotube, such as by soldering the sphere both front and back on thehypotube. The majority or the entire surface of the spherical electrode35 remains uninsulated. The remainder of the hypotube is preferablyinsulated so that the sphere-shaped distal end can act as the electrode.For example, the hypotube can be covered with an insulating materialsuch as a coating of parylene. The interior lumen of the hypotube islined by the inner sheath 28 which is attached to the flaired distal endof the hypotube by adhesive such as epoxy.

Surrounding the secondary lead 31 and sphere-shaped electrode 35 are aplurality of primary leads 30 which preferably have a flat rectangularstrip shape and can act as arms. As illustrated in FIG. 11, theplurality of primary leads are preferably connected to common conductiverings 62. This configuration maintains the position of the plurality ofprimary leads, while reducing the number of internal electricalconnections. The rings 62 are attached to the inner sheath 28. Theposition of the rings and the primary leads relative to the outer sheathfollows that of the inner sheath. As earlier described, the hypotube ofthe secondary lead 31 is also attached to the inner sheath 28. Twoseparate conductive rings can be used so that the polarity of differentprimary leads can be controlled separately. For example, adjacentprimary leads can be connected to one of the two separate conductiverings so that the adjacent leads can be switched to have either oppositepolarities or the same polarity. The rings are preferable spaced closelytogether, but remain electrically isolated from one another along theinner sheath. Both the rings and the hypotube are coupled with the innersheath, and the primary leads 30 that are connected to the rings movetogether with and secondary lead while remaining electrically isolatedfrom one another. Epoxy or another suitable adhesive can be used toattach the rings to the inner sheath. The primary leads from therespective rings each alternate with each other along the circumferenceof the inner sheath. The insulation along the underside of the leadsprevents an electrical short between the rings.

The ring and primary leads are attached together to act as cantileverswhere the ring forms the base and the rectangular primary leads operateas the cantilever arms. The leads 30 are connected to the ring and areformed to have an arc or bend such that the leads act as arms which tendto spring outwardly away from the catheter and toward the surroundingvenous tissue. Insulation along the underside of the leads and the ringsprevents unintended electrical coupling between the leads and theopposing rings. Alternately, the leads are formed straight and connectedto the ring at an angle, such that the leads tend to expand or springradially outward from the ring. The angle at which the leads areattached to the ring should be sufficient to force the primary distalends and electrodes 34 through blood and into apposition with the veinwall. Other properties of the primary leads 30, such as lead shape andinsulation thickness, affect the push force of the lead and the degreeof arc or bend must be adjusted to compensate for these factors. Therectangular cross section of the leads 30 can provide increasedstability in the lateral direction while allowing the necessary bendingin the radial direction. The leads 30 are less likely to bend sidewayswhen expanded outward, and a uniform spacing between leads is moreassured. Uniform spacing between the leads 30 and the distal endspromotes uniform heating around the vein by the electrodes 34.

The distal ends of the primary leads 30 are uninsulated to act aselectrodes 34 having a spoon or hemispherical shape. The leads can bestamped to produce an integral shaped electrode at the distal end of thelead. The uninsulated outer portion of the distal end electrode 34 whichis to come into apposition with the wall of the anatomical structure ispreferably rounded and convex. The flattened or non-convex inner portionof the distal end is insulated to minimize any unintended thermaleffect, such as on the surrounding blood in a vein. The distal endelectrodes 34 are configured such that when the distal ends are forcedtoward the inner sheath 12, as shown in FIG. 10 a, the distal endscombine to form a substantially spherical shape with a profile smallerthan the profile for the spherical electrode 35 at the secondary distalend.

The outer sheath 12 can slide over and surround the primary andsecondary leads 30, 31. The outer sheath 12 includes an orifice which isdimensioned to have approximately the same size as the sphericalelectrode 35 at the secondary distal end which functions as anelectrode. A close or snug fit between the electrode 35 at the secondarydistal end and the orifice of the outer sheath 12 is achieved. Thisconfiguration provides an atruamatic tip for the catheter. The electrode35 secondary distal end is preferably slightly larger than the orifice.The inner diameter of the outer sheath 12 is approximately the same asthe reduced profile of the combined primary distal end electrodes 34.The diameter of the reduced profile of the combined primary distal endelectrodes 34 is preferably less than the inner diameter of the outersheath.

A fluid port (not shown) can communicate with the interior of the outersheath 12 so that fluid can be flushed between the outer sheath 12 andthe inner sheath 28. Alternately, a fluid port can communicate with acentral lumen 48 in the hypotube which can also accept a guidewire. Aspreviously stated, the catheter 10 can be periodically flushed withsaline which can prevent the buildup of biological fluid, such as blood,within the catheter 10. A guide wire can be introduced through the lumen48 for use in guiding the catheter to the desired treatment site. Aspreviously described, a fluid can be flushed or delivered though thelumen as well. If a central lumen is not desired, the lumen of thehypotube can be filled with solder.

Preferably, the primary leads 30 and the connecting rings are connectedto a power source 22 such that the polarity of the leads may be switchedas desired. This allows for the electrode device 24 to operate in eithera bipolar or a monopolar configuration. When adjacent primary leads 30have opposite polarity, a bipolar electrode operation is available. Whenthe primary leads 30 are commonly charged a monopolar electrodeoperation is available in combination with a large return electrode padplaced in contact with the patient. When the primary leads 30 arecommonly charged, and a secondary lead 31 has an opposite polarity, abipolar electrode operation is available. More or fewer leads may beused. The number of leads can be dependent on the size or diameter ofthe hollow anatomical structure to be treated.

Although not shown, it is to be understood that the catheter 10 caninclude a temperature sensor, such as a thermocouple, mounted in placeon the distal end or electrode 34 so that the sensor is substantiallyflush with the exposed surface of the electrode 34. The sensor sensesthe temperature of the portion of the anatomical tissue that is inapposition with the exposed electrode surface. Application of the RFenergy from the electrodes 34 is halted or reduced when the monitoredtemperature reaches or exceeds the specific temperature that wasselected by the operator, such as the temperature at which anatomicaltissue begins to cauterize. Other techniques such as impedancemonitoring, and ultrasonic pulse echoing can be utilized in an automatedsystem which shuts down or regulates the application of RF energy fromthe electrodes to the venous section when sufficient shrinkage of thevein is detected and to avoid overheating the vein.

Referring now to FIGS. 12 through 14, in the operation of one embodimentof the catheter 10, the catheter is inserted into a hollow anatomicalstructure, such as a vein. Fluoroscopy, ultrasound, an angioscopeimaging technique, or another technique may be used to direct andconfirm the specific placement of the catheter in the vein. The actuatoris then operated to retract the outer sheath 12 to expose the leads 30,31. As the outer sheath no longer restrains the leads, the primary leads30 move outward relative to the axis defined by the outer sheath, whilethe secondary lead 31 remains substantially linear along the axisdefined by the outer sheath. The primary leads 30 continue to moveoutward until the distal end electrode 34 of the primary leads areplaced in apposition with the vein wall 54 occurs and the outwardmovement of the primary leads 30 is impeded. The primary leads 30contact the vein along a generally circumferential area of the vein wall54. This outward movement of the primary leads 30 occurs in asubstantially symmetrical fashion so that the primary distal endelectrodes 34 are substantially evenly spaced. The central-leadelectrode 35 is suspended within the vein without contacting the veinwall 54.

When the electrodes 34 are positioned at the treatment site of the vein,the power supply 22 is activated to provide suitable RF energy. In abipolar operation, the primary leads 30 are initially charged such thatadjacent leads are oppositely charged while the secondary lead iselectrically neutral. These multiple pairs of oppositely charged leads30 form active electrode pairs to produce an RF field between them, andform a symmetrical RF field pattern along a circumferential band of thevein wall to achieve a uniform temperature distribution along the veinwall being treated.

The RF energy produces a thermal effect which causes the venous tissueto shrink, reducing the diameter of the vein. As shown in FIG. 13, theenergy causes the vein wall 54 to collapse until further collapse isimpeded by the electrodes 34. The electrodes are pressed closer togetherby the shrinking vein wall. The electrodes 34 are pressed together toassume a reduced profile shape which is sufficiently small so that thevein is effectively ligated. Upon collapse of the vein wall 54 aroundthe primary-lead electrodes 34, the polarity of the primary-leadelectrodes is switched so that all of the primary-lead electrodes arecommonly charged. The secondary-lead electrode 35 is then charged sothat its polarity is opposite that of the primary-lead electrodes 34.Where the primary electrodes 34 and the secondary electrode 35 arespaced sufficiently close together, when the vein wall collapses aroundthe primary lead electrodes, the electrode at the distal end of thesecondary lead can also come into contact with the a portion of the veinwall so that an RF field is created between the primary electrodes 34and the secondary electrode 35.

The catheter 10 is pulled back to ensure apposition between theelectrodes at the distal ends of the leads and the vein wall. When thecatheter 10 is being pulled back, the primary-lead electrodes 34 remainin apposition with the vein wall 54 while the secondary-lead electrode35 comes in contact with the portion of the vein wall previouslycollapsed by the primary-lead electrodes 34. RF energy passes throughthe venous tissue between the primary-lead electrodes 34 and thesecondary-lead electrode 35. Ligation as the catheter is being retractedproduces a lengthy occlusion which is stronger and less susceptible torecanalization than an acute point occlusion.

In a monopolar operation, the secondary-lead electrode 35 remainsneutral, while the primary leads 30 are commonly charged and act inconjunction with an independent electrical device, such as a largelow-impedance return pad (not shown) placed in external contact with thebody, to form RF fields substantially evenly spaced around thecircumference of the vein. The thermal effect produced by those RFfields along the axial length of the vein wall causes the vein wall tocollapse around the primary-lead electrodes. Upon collapse of the veinwall, the secondary-lead electrode is charged to have the same polarityas that of the primary-lead electrodes. The electrode device isretracted as described in the bipolar operation.

In either bipolar or monopolar operation the application of RF energy issubstantially symmetrically distributed through the vein wall. Aspreviously described, the electrodes should be spaced no more than 4 or5 millimeters apart along the circumference of the vein, which definesthe target vein diameter for a designed electrode catheter. Where theelectrodes are substantially evenly spaced in a substantiallysymmetrical arrangement, and the spacing between the electrodes ismaintained, a symmetrical distribution of RF energy increases thepredictability and uniformity of the shrinkage and the strength of theocclusion.

As shown in FIG. 14, after the electrodes 34 come into apposition withthe vein wall (FIG. 12), and before the energy is applied to ligate thevein (FIG. 13), an external tourniquet, such as an elastic compressivewrap or an inflatable bladder with a window transparent to ultrasound,is used to compress the anatomy, such as a leg, surrounding thestructure to reduce the diameter of the vein. Although the compressiveforce being applied by the tourniquet may effectively ligate the vein,or otherwise occlude the vein by flattening the vein, for certain veins,this compressive force will not fully occlude the vein. A fixed diameterelectrode catheter in this instance would not be effective. Theelectrodes 34 which are expanded outward by the formed leads 30 canaccommodate this situation.

The reduction in vein diameter assists in pre-shaping the vein toprepare the vein to be molded to a ligated state. The use of an externaltourniquet also exsanguinates the vein and blood is forced away from thetreatment site. Coagulation of blood during treatment can be avoided bythis procedure. Energy is applied from the electrodes to theexsanguinated vein, and the vein is molded to a sufficiently reduceddiameter to achieve ligation. The external tourniquet can remain inplace to facilitate healing.

The catheter can be pulled back during the application of RF energy toligate an extensive section of a vein. In doing so, instead of a singlepoint where the diameter of the vein has been reduced, an extensivesection of the vein has been painted by the RF energy from the catheter.Retracting the catheter in this manner produces a lengthy occlusionwhich is less susceptible to recanalization. The combined use of theprimary and secondary electrodes can effectively produce a reduceddiameter along an extensive length of the vein. The catheter can bemoved while the tourniquet is compressing the vein, of after thetourniquet is removed.

Where the catheter includes a fluid delivery lumen, fluid can bedelivered to the vein before RF energy is applied to the vein. Thedelivered fluid displaces blood from the treatment site to ensure thatblood is not present at the treatment site, even after the tourniquetcompresses the vein.

Where the tourniquet is an inflatable bladder with a window transparentto ultrasound, an ultrasound transducer is used to monitor theflattening or reduction of the vein diameter from the compressive forcebeing applied by the inflating bladder. The window can be formed frompolyurethane, or a stand-off of gel contained between a polyurethanepouch. A gel can be applied to the window to facilitate ultrasoundimaging of the vein by the transducer. Ultrasound visualization throughthe window allows the operator to locate the desired venous treatmentarea, and to determine when the vein has been effectively ligated oroccluded. Ultrasound visualization assists in monitoring any pre-shapingof the vein in preparation of being molded into a ligated state by thethermal effect produced by the RF energy from the electrodes.

After completing the procedure for a selected venous section, theactuator causes the leads 30 to return to the interior of the outersheath 12. Once the leads 30 are within the outer sheath 12, thecatheter 10 may be moved to another venous section where the ligationprocess is repeated.

The description of the component parts discussed above are for acatheter to be used in a vein ranging in size from 2 mm (0.08 in) to 10mm (0.4 in) in diameter. It is to be understood that these dimensions donot limit the scope of the invention and are merely exemplary in nature.The dimensions of the component parts may be changed to configure acatheter 10 that may be used in various-sized veins or other anatomicalstructures.

Although described above as positively charged, negatively charged, oras a positive conductor or negative conductor, these terms are used forpurposes of illustration only. These terms are generally meant to referto different electrode potentials and are not meant to indicate that anyparticular voltage is positive or negative. Furthermore, other types ofenergy such as light energy from fiber optics can be used to create athermal effect in the hollow anatomical structure undergoing treatment.

While several particular forms of the invention have been illustratedand described, it will be apparent that various modifications can bemade without departing from the spirit and scope of the invention.Accordingly, it is not intended that the invention be limited, except asby the appended claims.

1-14. (canceled)
 15. A method of treating a vein, the method comprising:introducing an elongate energy delivery device into a vein having aninner wall; pre-shaping the vein by moving the inner wall of the veintoward a distal portion of the energy delivery device, independently ofthe energy delivery device; applying energy from the distal portion ofthe energy delivery device to the vein to create a thermal effect in thevein so as to effectively occlude the vein; moving the energy deliverydevice along the vein during the application of energy to form aneffective occlusion along the area of the vein where the energy deliverydevice is moved during the application of energy.
 16. The method ofclaim 15, wherein pre-shaping the vein comprises reducing the diameterof the vein, and applying energy comprises causing the vein to durablyassume a diameter at least as small as the reduced diameter achieved viathe pre-shaping.
 17. The method of claim 15 or 16, wherein the elongateenergy delivery device comprises a fiber optic and applying energycomprises applying light energy with the fiber optic.
 18. The method ofclaim 15 or 16, wherein the elongate energy delivery device comprises acatheter and applying energy comprises delivering electrical energy tothe catheter.
 19. The method of claim 18, wherein the catheter haselectrodes and applying energy comprises applying electrical energy fromthe electrodes.
 20. The method of claim 15, further comprising forming alengthy occlusion along the area of the vein where the elongate energydelivery device is moved during the application of energy.
 21. Themethod of claim 15, further comprising delivering fluid to the veinwhere the distal portion of the elongate energy delivery device islocated.
 22. The method of claim 15, wherein pre-shaping the veincomprises compressing the anatomy surrounding the vein at the locationof the distal portion of the elongate energy delivery device.
 23. Themethod of claim 15, wherein pre-shaping the vein comprises using anelastic compressive wrap around the anatomy surrounding the vein at thelocation of the distal portion of the elongate energy delivery device.24. The method of claim 15, wherein applying energy is performed whilethe vein is pre-shaped.
 25. A method of treating a vein, the methodcomprising: inserting an elongate energy delivery device into a lumen ofthe vein and advancing the elongate energy delivery device along thelumen to a treatment site; narrowing the vein at the treatment sitewhile the energy delivery device is present, independently of the energydelivery device; applying energy from the energy delivery device to thevein to create a thermal effect in the vein so as to occlude the vein;retracting the energy delivery device along the vein during theapplication of energy to form an occlusion along the area of the veinwhere the energy delivery device is retracted during the application ofenergy.
 26. The method of claim 25, wherein narrowing the vein comprisesreducing the diameter of the vein, and applying energy comprises causingthe vein to durably assume a diameter at least as small as the reduceddiameter achieved via the narrowing.
 27. The method of claim 25 or 26,wherein the elongate energy delivery device comprises a fiber optic andapplying energy comprises applying light energy with the fiber optic.28. The method of claim 25 or 26, wherein the elongate energy deliverydevice comprises a catheter and applying energy comprises deliveringelectrical energy to the catheter.
 29. The method of claim 28, whereinthe catheter has electrodes and applying energy comprises applyingelectrical energy from the electrodes.
 30. The method of claim 25,further comprising forming a lengthy occlusion along the area of thevein where the elongate energy delivery device is retracted during theapplication of energy.
 31. The method of claim 25, further comprisingdelivering fluid to the vein at the treatment site.
 32. The method ofclaim 25, wherein narrowing the vein comprises compressing the anatomysurrounding the vein at the treatment site.
 33. The method of claim 25,wherein narrowing the vein comprises using an elastic compressive wraparound the anatomy surrounding the vein at the treatment site.
 34. Themethod of claim 25, wherein applying energy is performed while the veinis narrowed.